The process of ligation of internal hemorrhoids is decades old. The principal of ligation is strangulation of redundant hemorrhoidal tissue. This is achieved by placing a rubber band (a “ligature”) over hemorrhoidal tissue that is pinched or suctioned into an open tube.
One such prior art ligator is used with an endoscope. This type of ligator is attached to the tip of the endoscope, introduced into the rectum, and retroflexed toward one or more hemorrhoids to be ligated. The one or more hemorrhoids are suctioned into the ligator, and the ligator then applies ligating bands to each such hemorrhoid. This endoscope-based procedure allows the operator to directly visualize the hemorrhoid before and during the ligation process; but this endoscopic process is complex, requires extensive training, and requires use of an expensive endoscope in an endoscopy unit or operating room setting.
Similar and other ligators have been in use for many years to treat symptomatic internal hemorrhoids in outpatient ambulatory gastroenterology (GI) or surgical practices. These devices include the CRH O'Reagon Disposible Ligator made by CRH Medical, the Short-Shot Saeed Hemorrhoidal Multi-Band Ligator by made by Wilson Cook Medical, and the Haemoband made by Haemoband Surgical Ltd.
The CRH O'Regan procedure includes use of an anoscope to identify the location of internal hemorrhoids. If hemorrhoids are found, the anoscope is removed and a single band is loaded onto the tip of the ligator. The ligator is blindly inserted into the rectum. The tip of the ligator is then directed toward the location of a previously identified hemorrhoidal column. While holding the ligator with one hand, suction is applied with the other hand and tissue is pulled into the ligator, and the ligating band is deployed by sliding an overtube over the end of the ligator. If more banding is needed, then the ligator must be removed and re-loaded with another band. While this CRH technique allows for hand-applied suctioning and lower cost than endoscope-based techniques, this technique requires repeated instrumentation of the anus, blind ligation, application of only a single band during a given insertion of the ligator, and difficult reloading of bands on the tip of the device.
The Short-Shot Ligator is a hand-held instrument with capacity for up to four preloaded bands. After insertion of an anoscope, and identification of hemorrhoids, the anoscope is left in place and the ligator is pushed through the anoscope. The tip of the ligator is then approximated to the tissue, which is suctioned into the ligator using an external suctioning system. The bands are then deployed by using a string mechanism manipulated by the thumb. While this technique allows deployment of multiple, preloaded bands in a single insertion of the ligator, it requires use of an external suctioning system not available outside of an endoscopic or surgical setting. This procedure also provides only semi-direct visualization. While the anoscope is in place, target hemorrhoidal tissue can be seen only until the ligator is introduced into the anoscope. At that point, direct visualization is lost and the ligation procedure requires that the practitioner approximate the tip of the ligator to the target hemorrhoid blindly (meaning that the practitioner tries to put the tip where the practitioner remembers the hemorrhoids to be in the prior inspection). This approximation may be inaccurate and does not allow direct visualization of the amount of suctioned hemorrhoidal tissue. This may lead to suctioning of a small amount of hemorrhoidal tissue leading to limited success of the procedure.
The Haemoband Ligator is similar to the Short Shot but differs in that it can deploy multiple preloaded bands by a hand-trigger mechanism. This ligator is used in conjunction with a lighted anoscope. Use of the anoscope and approximation of the tip of the ligator is identical to the Short-Shot Ligator, resulting in the same issues described above for the Short-Shot Ligator.